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Regulatory Affairs Manager
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Location
Winterthur
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Salary
Negotiable
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Discipline
Regulatory
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Reference
PR/449670_1692977840
Join a leading Medical Device Manufacturer in expanding their Regulatory team. You would be joining an established team of 6 people. Working with life saving medical devices
Your main tasks
- Carrying out approvals for medical devices with authorities worldwide
- Creation and maintenance of registration documents
- Supervision of development projects regarding regulatory affairs
- Evaluation of amendments
- Negotiation of contracts with customers regarding RA aspects
- Advising and supporting clients on regulatory issues and drafting
- of the registration documents for medical devices and combination products
- Correspondence with authorities for inquiries and reports from authorities
- Assistance with customer and authority audits
- General QM tasks such as training, creation of Q documents, etc.
Your profile
- Technical basic training and/or a completed scientific degree
- 3 years of experience in regulatory affairs in the life sciences industry
- Experience working with Class IIb/III Medical Deices
- High quality awareness and pronounced personal responsibility
- Customer-oriented and communicative personality
- Stylish knowledge of German
- very good knowledge of English
